Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy
Sunday December 9, 5:40 pm ET
- VELCADE based therapy achieved highly significant improvement across all efficacy endpoints including overall survival -
ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the presentation of results from the 682 patient, randomized, Phase III VISTA(1) trial. These patients with previously untreated multiple myeloma (MM) were ineligible for stem cell transplantation (SCT). The trial compared VELCADE, melphalan and prednisone (VcMP) to melphalan and prednisone (MP) alone, a recognized standard of care in this treatment setting. These data were selected for an oral presentation at the American Society of Hematology (ASH) 49th Annual Meeting in Atlanta, Ga., December 8-11, 2007.
"The goal of therapy is long-term survival and complete remission is a well-known indicator for survival," said Professor Jesus San-Miguel, M.D., Hematology Department Head, University Hospital of Salamanca and Principal Investigator of the trial. "Data from this rigorously-controlled trial clearly show that VELCADE based therapy should be a standard of care for previously untreated patients, who are not able to receive stem cell transplantation."
Data from the large international clinical trial were presented by Professor San-Miguel. Responses were evaluated by the commonly used M-protein levels measured in serum or urine by a centralized laboratory as well as the most stringent European Group for Blood and Marrow Transplantation (EBMT) criteria:
-- Immunofixation-negative complete remission (CR) rate of 35 percent in the VcMP arm compared to 5 percent with MP (p<0.000001); EBMT criteria showed a CR rate of 30 percent in the VcMP arm compared to 4 percent with MP
-- The median duration of response was 24 months for patients with CR in VcMP compared to 13 months with MP
-- Time-to-disease progression (TTP) in the VcMP arm of 24 months compared to 17 months with MP (p=0.0000001)
-- VcMP demonstrated statistical significance in overall survival with a 40 percent reduction in risk of death (p=0.0078); median survival was not reached despite a short follow-up of 16 months
-- The median treatment duration was 46 weeks and discontinuation due to adverse events was low and similar in both arms
"This VELCADE based therapy offers patients durable and complete remissions, formerly only accessible to transplant patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are filing a sNDA this month to seek approval in this important treatment setting, which could significantly increase the number of patients eligible to benefit from VELCADE."
Patients in the VcMP arm received VELCADE at 1.3 mg/m2 twice weekly in weeks one, two, four and five for four six-week cycles (eight doses per cycle), followed by once weekly on weeks one, two, four and five for five six- week cycles (four doses per cycle) in combination with melphalan at 9 mg/m2 and prednisone at 60 mg/m2 once daily on days 1 through 4 of each cycle. Patients in the MP arm received nine six-week cycles of MP once daily on days 1 through 4. For both groups, treatment continued for a maximum of 54 weeks (52 vials) with a median number of 46 weeks (44 vials) reported in the trial. The safety profile of VcMP was as expected based on the known safety profile of each of the three individual agents in the combination, including neutropenia, thrombocytopenia, anemia and peripheral neuropathy. |
